Clinical Data Collection of Patients Treated With High Intensity Focused Ultrasound (HIFU) by the Focal One for Their Prostate Cancer. (One registry)

June 10, 2026 updated by: EDAP TMS S.A.
The aim of the registry is to gather real-life data to evaluate the clinical performance and safety of medical devices in patients who have been treated with HIFU thank to the Focal One device for their prostate cancer.

Study Overview

Status

Recruiting

Conditions

Detailed Description

It is a prospective and retrospective register.

Study Type

Observational

Enrollment (Estimated)

3000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Aix-en-Provence, France, 13080
        • Recruiting
        • Hôpital privé Aix en provence
        • Contact:
        • Principal Investigator:
          • David BARRIOL, Dr
      • Besançon, France, 25056
        • Recruiting
        • Clinique Saint vincent
        • Contact:
        • Principal Investigator:
          • Vincent BAILLY, Dr
      • Colmar, France, 68000
        • Recruiting
        • Hôpital Civil Colmar
        • Contact:
        • Principal Investigator:
          • Santiago LOPEZ, dr
      • Lyon, France, 69000
        • Recruiting
        • Hôpital Edouard Heriot
        • Principal Investigator:
          • Sébastien CROUZET, Pr
        • Contact:
      • Nantes, France, 44000
        • Recruiting
        • Clinique Nantes Atlantis
        • Contact:
        • Principal Investigator:
          • Eric POTIRON, Dr

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients Being treated for prostate cancer with the Focal One device

Description

Inclusion Criteria:

  • Being treated for prostate cancer with the Focal One device
  • Patient does not object and consent* to the collection of clinical data in the registry

Exclusion Criteria:

  • Patient deprived of liberty following a judicial or administrative decision
  • Patient under guardianship or curatorship * if applicable according to local regulation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To monitor the safety of HIFU treatment with the Focal One in patients treated for prostate cancer.
Time Frame: From HIFU treatment up to 5 years post-HIFU
Safety will be assessed by collecting adverse events related to HIFU treatment.
From HIFU treatment up to 5 years post-HIFU

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PSA values after HIFU treatment
Time Frame: From HIFU treatment up to 5 years post-HIFU
Oncological outcomes will be assessed using PSA measurements obtained as part of routine care. The outcome will be reported as PSA values measured during follow-up after HIFU treatment.
From HIFU treatment up to 5 years post-HIFU
Incidence of local recurrence detected by prostate MRI after HIFU treatment
Time Frame: From HIFU treatment up to 5 years post-HIFU
Local recurrence will be assessed using prostate MRI performed as part of routine care. The outcome will be reported as the number and proportion of patients with imaging findings suspicious for local recurrence.
From HIFU treatment up to 5 years post-HIFU
Prostate biopsy results after HIFU treatment
Time Frame: From HIFU treatment up to 5 years post-HIFU
Oncological outcomes will be assessed using prostate biopsy results obtained as part of routine care. The outcome will be reported as the number and proportion of patients with positive biopsy findings during follow-up after HIFU treatment.
From HIFU treatment up to 5 years post-HIFU
To estimate the retreatment rate of patients treated with HIFU
Time Frame: From HIFU treatment up to 5 years post-HIFU
The rate and timing of retreatment (radical prostatectomy, radiotherapy, cryotherapy, HIFU, other focal treatment) after HIFU treatment will be assessed using data from the patient's clinical follow-up.
From HIFU treatment up to 5 years post-HIFU

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

EDAP TMS S.A.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2023

Primary Completion (Estimated)

April 1, 2031

Study Completion (Estimated)

April 1, 2031

Study Registration Dates

First Submitted

March 5, 2026

First Submitted That Met QC Criteria

June 10, 2026

First Posted (Actual)

June 12, 2026

Study Record Updates

Last Update Posted (Actual)

June 12, 2026

Last Update Submitted That Met QC Criteria

June 10, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HIFU/EU/22.02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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